510(k) Report

FDA applicant

Expanse Medical, Inc.

Pleasanton, CA3 decisions2024–20260 recalls

FDA records 3 decisions for Expanse Medical, Inc. (Pleasanton, CA) from 2024 to 2026: 3 510(k) clearances. Most are in product codes QEZ (Aspiration Thrombectomy Catheter) and QEW (Peripheral Mechanical Thrombectomy With…). Since 2016 its 510(k)s took a median of 81 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Expanse Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 12026 (partial year): 1
2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Expanse Medical, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Expanse Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QEZAspiration Thrombectomy Catheter2decisions
  • QEWPeripheral Mechanical Thrombectomy With Aspiration1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 81 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 98 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K234073ICE Aspiration SystemExpanse Medical, Inc. · 20241cites it
  • K251488FLOWRUNNER Aspiration SystemExpanse Medical, Inc. · 20251cites it

What has FDA decided for it lately?

  • K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc. · 2026
  • K251488FLOWRUNNER Aspiration SystemExpanse Medical, Inc. · 2025
  • K234073ICE Aspiration SystemExpanse Medical, Inc. · 2024

All 3 as Expanse Medical, Inc. →